Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT). (WinterBAT)
The Impact of Winter Swimming on Brown Adipose Tissue Recruitment and Metabolic Health in Middel-aged Obese Pre-diabetic Subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Brown fat (BAT) is an energy-consuming tissue. Long-term activation of BAT in adults increases clearance of blood glucose and non-esterified fatty acids (NEFA), insulin sensitivity and metabolic rate. Moreover, adipokines released from BAT, known as batokines, represent a promising but currently unexplored area in terms of metabolic regulation. Cooling activates BAT; however, current cooling protocols fail to activate BAT in a large part of the population. Whether this failure in activation is related to biology, inefficient detection or cooling protocols is unknown. With our initial acute cooling study (protocol number: H-16038581), these protocols have successfully been optimized whereupon novel batokines will be identified. Having established a methodology for assessing BAT activity and batokine profiles, a longer-term cooling intervention (winter swimming) will be performed to examine the effect of repetitive cold-water exposure on BAT activity. Obese pre-diabetic subjects will be included in a 4-month supervised winter swimming (WS) intervention.
It is hypothesized, that repetitive cold-water exposure constituted by WS, increase BAT activation and volume, followed by improved glycemic control in obese pre-diabetic subjects.
Method The study is a randomized controlled, parallel-group intervention study. The investigator will recruit 30 obese pre-diabetic non-winter-swimmers to participate in a WS intervention group (n=15) or control group (n=15) with no WS activities. Subjects will either be randomized to the WS group, who will winter-swim 4 months, 2-3 times/week including sauna-visits if desired, or control conditions with no WS during the 4 months (October to May).
Main aims
- To assess whether WS will have an immediate effect on BAT recruitment or function.
- To assess whether WS will have an effect on glycemic control.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Center for Inflammation and Metabolism/ Center for Physical Activity Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Waist circumference above 80 cm for women and 94 cm for men.
- BMI > 25 but <40 kg/m2
- Age > 40 years.
- Low to moderate physical activity level (no physical activity or on average 30 minutes of moderate physical activity per day and not more than 3 hours of training pr. Week)
Subjects will be included in either one of these cases after the screening:
- Fasting plasma glucose above 5.6 millimol per liter (mmoL/L).
- HbA1C >39 millimol per mol (mmol/mol).
- 2 hour plasma glucose after a 75 g. oral glucose tolerance test (OGTT) above 7.8 mmol/L.
Exclusion Criteria:
- Winter swimmer
- Any history of Cancer,
- Clinically significant liver, kidney, heart, inflammatory or lung-disease.
- Pregnancy
- Taking medication (not for hay fever), including glucose-lowering treatment.
- HbA1c >55 mmol/mol and/or 2-h plasma glucose in the 75-g OGTT > 15 mmol/L, fasting plasma glucose above 6.9.
- Iron deficiency
- Increased International Normalised Ratio for coagulation (INR).
- Femoral hernia, vene prostheses (pants prosthesis), thrombs in v. Femoralis.
- Abnormal ultrasound echocardiography of the heart found at the health-examination day.
- Contraindications to cold exposure including severe Raynauds disease.
- History of alcohol abuse or use of more than 14 units pr. Week.
- History of drug abuse, including marihuana.
- Smoking including occasional smoking.
- Pacemaker or other electronics implanted in the body.
- Claustrophobia, communication problems, including understanding the experimental protocol.
- History of contrast allergy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Winter Swimmers
4 Months of supervised winter swimming.
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Supervised Winter Swimming in Copenhagen
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Placebo Comparator: Control group
No winter swimming activities.
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No winter swimming activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference between groups in change in brown adipose tissue (BAT) activity during cooling
Time Frame: Day 0 (before intervention) and Day 120 (after intervention)
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BAT activity is measured using positron emission tomography (PET)- Computer tomography (CT) scan.
The PET-CT scan uses a glucose-radiotracer (fludeoxyglucose-18 (FDG)) to measure the glucose uptake in BAT, which is associated with BAT activity.
FDG is injected following one hour of cooling and the subjects are scanned following one additional hour of cooling.
The subjects are continuously cooled throughout the scanning procedure.
Difference between groups in change in FDG tracer uptake (post minus pre intervention) during 1,5 hours of cooling is calculated.
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Day 0 (before intervention) and Day 120 (after intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference between groups in change in glycemic control
Time Frame: Day 0 (before intervention) and Day 120 (after intervention)
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Glycemic control is measured using a 4 hour mixed meal tolerance test.
Difference between groups in change in the mean MMTT glucose levels during the MMTT (post minus pre intervention) will be calculated.
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Day 0 (before intervention) and Day 120 (after intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Camilla Schéele, PhD, Rigshospitalet, Denmark
Publications and helpful links
General Publications
- van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718. Erratum In: N Engl J Med. 2009 Apr 30;360(18):1917.
- Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22.
- Hanssen MJ, Hoeks J, Brans B, van der Lans AA, Schaart G, van den Driessche JJ, Jorgensen JA, Boekschoten MV, Hesselink MK, Havekes B, Kersten S, Mottaghy FM, van Marken Lichtenbelt WD, Schrauwen P. Short-term cold acclimation improves insulin sensitivity in patients with type 2 diabetes mellitus. Nat Med. 2015 Aug;21(8):863-5. doi: 10.1038/nm.3891. Epub 2015 Jul 6.
- Hanssen MJ, van der Lans AA, Brans B, Hoeks J, Jardon KM, Schaart G, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Short-term Cold Acclimation Recruits Brown Adipose Tissue in Obese Humans. Diabetes. 2016 May;65(5):1179-89. doi: 10.2337/db15-1372. Epub 2015 Dec 30.
- Gibas-Dorna M, Checinska Z, Korek E, Kupsz J, Sowinska A, Krauss H. Cold Water Swimming Beneficially Modulates Insulin Sensitivity in Middle-Aged Individuals. J Aging Phys Act. 2016 Oct;24(4):547-554. doi: 10.1123/japa.2015-0222. Epub 2016 Aug 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-18015882 WinterBAT-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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